(77 days)
No
The summary describes a standard digital radiography system and its components, focusing on image acquisition, processing, storage, display, and export. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies. The image processing mentioned is typical for digital radiography systems and does not necessarily imply AI/ML.
No
The device is used for acquiring, processing, storing, and displaying digital radiographic images, which are diagnostic purposes, not therapeutic.
Yes
Explanation: The device is intended to acquire, process, store, display, and export digital radiographic images for all routine radiography examinations. These images are used by medical professionals to diagnose conditions, which makes the device a diagnostic tool.
No
The device description clearly outlines hardware components such as a patient support table, ceiling suspension, tube, flat panel detector, and x-ray generator, indicating it is a physical system, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for acquiring, processing, storing, displaying, and exporting digital radiographic images. This is related to medical imaging, not the examination of specimens derived from the human body (which is the core of IVD).
- Device Description: The description details a digital radiography system with components like an X-ray generator, flat panel detector, and patient support. These are all components of an imaging system, not a system for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. The device's function is to produce images based on the interaction of X-rays with the patient's body.
In summary, the DigitalDiagnost C90 is a medical imaging device used for diagnostic purposes through radiography, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The DigitalDiagnost C90 is intended to acquire, process, store, display and export digital radiographic images. The DigitalDiagnost C90 is suitable for all routine radiography examinations, including specialist areas like intensive care, trauma or pediatric work, excluding fluoroscopy, angiography and mammography.
Product codes (comma separated list FDA assigned to the subject device)
MQB, KPR, LLZ
Device Description
The DigitalDiagnost C90 is a high-end digital radiography system consisting of a height adjustable patient support table and a ceiling suspension consisting of a tube including a control handle used to acquire images with a flat panel fixed RAD detector. Additionally, different vertical stands for the radiography examinations are available. The ceiling suspension can be moved in longitudinal and lateral directions and additionally the tube can be tilted and rotated as well. The DigitalDiagnost C90 is configured with a Philips x-ray generator and a flat panel fixed RAD detector, Pixium 4343RCE (K170113 - February 9, 2017), together with the tube these components form the radiography Image Chain. As additional options, a portable detector (K141736 - July 25, 2014) can be used for free exposures as well as in the patient support table or in the vertical stand.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
This 510(k) premarket notification contains technical documentation which includes nonclinical verification and validation tests as well as image quality testing. Tests were performed on the proposed DigitalDiagnost C90 according to the following international and FDArecognized consensus standards:
- ISO 14971, Medical devices. Application of risk management to medical devices
- IEC 60601-1, Medical electrical equipment. General requirements for safety. Collateral standard. Safety requirements for medical electrical systems
- IEC 60601-1-2. Medical electrical equipment. General requirements for basic safety and essential performance. Collateral Electromagnetic compatibility. Requirements and tests
- IEC 60601-1-3. Medical electrical equipment. General requirements for basic safety and essential performance. Collateral Standard: Radiation protection in diagnostic X-ray equipment
- IEC 60601-2-54, Medical electrical equipment. Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
- IEC 6220-1, Medical electrical equipment. Characteristics of digital X-ray imaging devices. Determination of the detective quantum efficiency
- IEC 62304, Medical device software. Software life-cycle processes
- IEC 60601-1-6. General requirements for basic safety and essential performance -. Collateral standard: Usability
- Guidance for the Submission of 510(k)s for Solid State X-Ray Imaging Devices, issued September 1, 2016
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued May 11, 2005
- Pediatric Information for X-ray Imaging Device Premarket Notifications, Draft, issued May 10, 2012
- Guidance for the Submission of Premarket Notifications for Medical Image Management Device, issued July 27, 2000
The test results demonstrate that the proposed DigitalDiagnost C90 meets the acceptance criteria and is adequate for its intended use.
The proposed DigitalDiagnost C90 did not require a clinical study since substantial equivalence to the currently marketed and predicate device was demonstrated with the following attributes:
- Design features;
- Indication for use;
- Fundamental scientific technology:
- Non-clinical performance testing including validation; and
- Safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Philips Medical Systems DMC GmbH Ming Xiao Regulatory Affairs Manager Roentgenstrasse 24 Hamburg, 22335 DE GERMANY
January 11, 2019
Re: K182973
Trade/Device Name: DigitalDiagnost C90 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB, KPR, LLZ Dated: October 23, 2018 Received: October 26, 2018
Dear Ming Xiao:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Michael D. O'Hara For
Robert A. Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182973
Device Name
DigitalDiagnost C90
Indications for Use (Describe)
The DigitalDiagnost C90 is intended to acquire, process, store, display and export digital radiographic images. The DigitalDiagnost C90 is suitable for all routine radiography examinations, including specialist areas like intensive care, trauma or pediatric work, excluding fluoroscopy, angiography and mammography.
| Type of Use (Select one or both, as applicable) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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7. 510(k) Summary
510(k) Summary of Safety and Effectiveness
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.
- Date Prepared: revised January 09, 2019
- Manufacturer: Philips Medical Systems DMC GmbH Röntgenstraße 24 22335 Hamburg GERMANY Establishment registration number: 3003768251
- Contact Person: Ming Xiao Regulatory Affairs Manager Phone: +49 40 34971-2306 Fax: +49 40 5078-2425 E-mail: ming.xiao@philips.com
- Device Name: DigitalDiagnost C90
| Classification: | Classification Name: Solid State X-Ray Imager (Flat Panel/Digital Imager) |
|---|---|
| Classification Regulation: 21CFR 892.1680 | |
| Regulation Description: Stationary x-ray system | |
| Classification Panel: 90 -- Radiology | |
| Device Class: Class II | |
| Classification Product Code: MQB | |
| Secondary Product Codes: KPR, LLZ | |
| Predicate Device: | Trade Name: Philips Eleva Workspot for DigitalDiagnost |
| Manufacturer: Philips Medical System DMC | |
| 510(k) Clearance: K141736 - July 25, 2014 | |
| Classification Name: Solid State X-Ray Imager (Flat Panel/Digital Imager) | |
| Classification Regulation: 21CFR 892.1680 | |
| Classification Panel: 90 -- Radiology | |
| Device Class: Class II | |
| Product code: MQB | |
| Subsequent Product Code: KPR |
DigitalDiagnost C90 Premarket Notification – Traditional 510(k) Page 1 of 13
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| Reference | Trade Name: | Philips Bucky Vision | ||
|---|---|---|---|---|
| Device_1 (primary | ||||
| device): | Manufacturer: | Philips Medical System DMC | ||
| 510(k) Clearance: | K982795 - November 24, 1998 | |||
| Classification Name: | Solid State X-Ray Imager (Flat | |||
| Panel/Digital Imager) | ||||
| Classification Regulation: | 21CFR 892.1680 | |||
| Classification Panel: | 90 -- Radiology | |||
| Device Class: | Class II | |||
| Product code: | ||||
| Subsequent Product Code: | MQB | |||
| KPR | ||||
| Reference | Trade Name: | Eleva Workspot with SkyFlow | ||
| Device_2: | Manufacturer: | Philips Medical System DMC | ||
| 510(k) Clearance: | K153318 - December 22, 2015 | |||
| Classification Name: | Solid State X-Ray Imager (Flat | |||
| Panel/Digital Imager) | ||||
| Classification Regulation: | 21CFR 892.1680 | |||
| Classification Panel: | 90 -- Radiology | |||
| Device Class: | Class II | |||
| Product code: | ||||
| Subsequent Product Code: | MQB | |||
| LLZ | ||||
| Reference | Trade Name: | Pixium 4343RCE | ||
| Device_3: | Manufacturer: | Philips Medical System DMC | ||
| 510(k) Clearance: | K170113 – February 9, 2017 | |||
| Classification Name: | Solid State X-Ray Imager (Flat | |||
| Panel/Digital Imager) | ||||
| Classification Regulation: | 21CFR 892.1680 | |||
| Classification Panel: | 90 -- Radiology | |||
| Device Class: | Class II | |||
| Product code: | MOB |
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Image /page/5/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and fill the majority of the frame. The background is plain white, which makes the blue letters stand out.
Device Description:
The DigitalDiagnost C90 is a high-end digital radiography system consisting of a height adjustable patient support table and a ceiling suspension consisting of a tube including a control handle used to acquire images with a flat panel fixed RAD detector. Additionally, different vertical stands for the radiography examinations are available. The ceiling suspension can be moved in longitudinal and lateral directions and additionally the tube can be tilted and rotated as well. The DigitalDiagnost C90 is configured with a Philips x-ray generator and a flat panel fixed RAD detector, Pixium 4343RCE (K170113 - February 9, 2017), together with the tube these components form the radiography Image Chain. As additional options, a portable detector (K141736 - July 25, 2014) can be used for free exposures as well as in the patient support table or in the vertical stand.
The proposed DigitalDiagnost C90 is considered substantially equivalent to the currently marketed and predicate device, Philips Eleva Workspot for DigitalDiagnost (K141736, July 25, 2014), previously designated with primary product code MQB and subsequent product code LLZ, in terms of indications for use and design characteristics. Nevertheless product code KPR -being also considered substantially equivalent- (based upon submission Philips Bucky Vision (K982795, November 24, 1998) is chosen for this new submission, because it refers back to a complete "stationary x-ray system".
The proposed DigitalDiagnost C90 incorporates the following features, previously cleared by FDA in the following reference devices:
| Design Feature/ Attribute | Currently Marketed and Reference Device - Philips Medical Systems |
|---|---|
| Primary device | Philips Bucky Vision (K982795, November 24, 1998) |
| Image Chain acquisition-station and workflow (Eleva Workspot) | Eleva Workspot with SkyFlow (K153318, December 22, 2015) |
| Fixed static detector | Pixium RCE (K170113, February 9, 2017) |
The Indications for Use for the proposed DigitalDiagnost C90 are as follows:
The DigitalDiagnost C90 is intended to acquire, process, store, display and export digital radiographic images. The DigitalDiagnost C90 is suitable for all routine radiography examinations, including specialist areas like intensive care, trauma or pediatric work, excluding fluoroscopy, angiography and mammography.
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Device History / Predicate Device for DigitalDiagnost C90:
| 510(k) | Decision
Date | Cleared
Device | Product
Code | Predicate
Device | Intended Use | Release Product |
|---------|------------------|-----------------------------------------------------------------------|-----------------|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| K982795 | 24.11.1998 | Philips
Bucky
Vision | MQB, KPR | K945278 | The Philips
BuckyVision is
intended for use
in general radio-
graphic exam-
inations and
applications
wherever con-
ventional
screen-film
system may be
used (excluding
fluoroscopy,
angiography
and mammo-
graphy). | DigitalDiagnost
Release 1 (issued
as Bucky Vision
for cleared
510(k)
declaration
K982795 in
1998) |
| K063781 | 05.01.2007 | Philips XD-
S Direct
Radiograph
y
Workstatio
n/Package | LLZ, MQB | K982795 | As part of a
radiographic
system, the
Philips XD-S
is intended to
acquire,
process, store,
display and
export digital
radiographic
images. The
Philips XD-S is
suitable for all
routine radio-
graphy exams,
including
specialist areas
like intensive
care, trauma, or
pediatric work,
excluding
mammography. | DigitalDiagnost
Release 2 |
| K090625 | 24.03.2009 | Wireless
Portable
Detector
FD-W17 | MQB | K982795
K063781 | As part of a
radiographic
system, the
Wireless
Portable
Detector FD-
W17 is intended
to acquire
digital radio-
graphic images.
The Wireless
Portable | DigitalDiagnost
Release 3 |
| 510(k) | Decision
Date | Cleared
Device | Product
Code | Predicate
Device | Intended Use | Release Product |
| | | | | | Detector FD-
W17 is suitable
for all routine
radiography
exams,
including
specialist areas
like intensive
care, trauma, or
pediatric work,
excluding
fluoroscopy,
angiography
and mammo-
graphy. | |
| K131483 | 07.10.2013 | Philips
Pixium
4343RC | MQB | K982795
K063781
K090625 | As part of a
radiographic
system, the
Philips Pixium
4343RC is
intended to
acquire digital
radiographic
images. The
Philips Pixium
4343RC is
suitable for all
routine radio-
graphy exams,
including
specialist areas
like intensive
care, trauma, or
pediatric work,
excluding
fluoroscopy,
angiography
and
mammography. | DigitalDiagnost
Release 4 |
| K141736 | 25.07.2014 | Philips
Eleva
Workspot
for
DigitalDiag
nost | MQB, LLZ | K090625 | As part of a
radiographic
system, the
Philips Eleva
Workspot with
SkyPlate
Detectors is
intended to
acquire,
process, store,
display and
export digital
radiographic | DigitalDiagnost
Release 4 with
SkyPlate
Detectors |
| 510(k) | Decision Date | Cleared Device | Product Code | Predicate Device | Intended Use | Release Product |
| K18xxxx | | DigitalDiagnost C90 | MQB, LLZ, KPR | K141736 | images. The Philips Eleva Workspot with SkyPlate Detectors is suitable for all routine radiography exams, including specialist areas like intensive care, trauma, or pediatric work, excluding fluoroscopy, angiography and mammography.
The Digital-Diagnost C90 is intended to acquire, process, store, display and export digital radio-graphic images. The Digital-Diagnost C90 is suitable for all routine radiography examinations, including specialist areas like intensive care, trauma or pediatric work, excluding fluoroscopy, angiography | DigitalDiagnost C90 |
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Image /page/7/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is white, providing a strong contrast that makes the word stand out.
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Image /page/8/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is white, providing a strong contrast that makes the word stand out.
Fundamental Scientific Technology:
The DigitalDiagnost C90 employs the same basic construction and fundamental scientific technology as the currently marketed and predicate Philips Eleva Workspot for DigitalDiagnost (K141736, July 25, 2014), with regards to the functionality of the following components: table, system-control, X-Ray tube, detector, and generator etc. (see the comparison table comparing
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the DigitalDiagnost C90 to the currently marketed and predicate Philips Eleva Workspot for DigitalDiagnost provided below).
The DigitalDiagnost C90 employs the following cleared features: fixed RAD detector (Pixium 4343RCE, K170113, February 9, 2017), wireless detectors (SkyPlate Detector, cleared by Eleva Workspot for DigitalDiagnost, K141736, July 25, 2014)) and the image chain acquisition-station and workflow (Eleva Workspot with SkyFlow, K153318, December 22, 2015). The fixed detector, wireless portable detectors, and the image chain and workstation of the DigitalDiagnost C90 are identical to the fixed detector, wireless portable detectors, and the image chain and workstation of the currently marketed and reference devices. Therefore, the fixed detector, wireless portable detectors, and the image chain and workstation employ identical fundamental scientific technology.
The outcome of this comparison demonstrates that the minor differences in the technological characteristics do not affect the safety or effectiveness of the DigitalDiagnost C90 when compared to the currently marketed and predicate Philips Eleva Workspot for DigitalDiagnost.
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Summary of technological characteristics: .
The DigitalDiagnost C90 has similar indications for use and technological characteristics as the predicate device, Philips Eleva Workspot for DigitalDiagnost. Comparisons of the technological characteristics demonstrate the substantial equivalence to the predicate device.
| | Predicate Device:
Philips Eleva Workspot
for DigitalDiagnost
Release 4 with SkyPlate
Detectors / (K141736) | Proposed Device:
DigitalDiagnost C90
(K18xxxx) | Discussion & Conclusion |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Table Features | | | |
| Height adjustable table (TH) | | | |
| Height adjustment | 51.5 cm to 91.5 cm
above floor, motorized
adjustment | 51.5 cm to 91.5 cm
above floor, motorized
adjustment | Equivalent; No impact to
safety or effectiveness of
the device. |
| Table weight | 335 kg | 335 kg | Equivalent; No impact to
safety or effectiveness of
the device. |
| Max. patient
weight | Static load center: 375
kg
Dynamic load center:
318 kg
Dynamic load off center:
210 kg | Static load center: 375
kg
Dynamic load center:
318 kg
Dynamic load off
center: 210 kg | Equivalent; No impact to
safety or effectiveness of
the device. |
| Table top Type | Floating table top of
sandwich design with
Getalit overlay | Floating table top of
sandwich design with
Getalit overlay | Equivalent; No impact to
safety or effectiveness of
the device. |
| Table top
Dimension | 240 cm x 75 cm | 240 cm x 75 cm | Equivalent; No impact to
safety or effectiveness of
the device. |
| Table top travel | • longitudinal: ±60 cm
• transverse: ±13 cm,
electromagnetic
brakes | • longitudinal: ±60
cm
• transverse: ±12 cm,
electromagnetic
brakes | Similar: Minor differences
in the table top travel does
not affect the safety or
effectiveness of the device. |
| Single side suspended table (TH-S) | | | |
| Height adjustment | 50.3 cm to 90.3 cm
motorized adjustment | 50.3 cm to 90.3 cm
motorized adjustment | Equivalent; No impact to
safety or effectiveness of
the device. |
| Table weight | 214 kg | 214 kg | Equivalent; No impact to
safety or effectiveness of
the device. |
| Max. patient
weight | 225 kg | •table top center: 225
kg
•end of table top: 135
kg | Equivalent; No impact to
safety or effectiveness of
the device. |
| Table top Type | Floating table top of
sandwich design with
Kevlar overlay, flat top | Floating table top of
sandwich design with
Kevlar overlay, flat
top | Equivalent; No impact to
safety or effectiveness of
the device. |
| | Predicate Device:
Philips Eleva Workspot
for DigitalDiagnost
Release 4 with SkyPlate
Detectors / (K141736) | Proposed Device:
DigitalDiagnost C90
(K18xxxx) | Discussion & Conclusion |
| Table top
Dimension | 260 cm x 75 cm | 260 cm x 75 cm | Equivalent; No impact to
safety or effectiveness of
the device. |
| Thickness of table
top | 4.7 cm | 4.7 cm | Equivalent; No impact to
safety or effectiveness of
the device. |
| Table top travel | • longitudinal: ±20 cm,
hydraulic brakes
• transverse: ±20 cm,
hydraulic brakes | • longitudinal: ±20
cm, hydraulic
brakes
• transverse: ±20 cm,
hydraulic brakes | Equivalent; No impact to
safety or effectiveness of
the device. |
| Patient coverage
with fixed RAD
detector | • longitudinal: 208 cm
• Transversal: 83 cm | • longitudinal: 208
cm
• Transversal: 83 cm | Equivalent; No impact to
safety or effectiveness of
the device. |
| Celling Suspension CSM | | | |
| Type | Four-part aluminum
telescopic column with
spring counter balanced
holder for X-ray tube
assembly; adaptable to
individual room heights | Four-part aluminum
telescopic column with
spring counter
balanced holder for X-
ray tube assembly;
adaptable to individual
room heights | Equivalent; No impact to
safety or effectiveness of
the device. |
| Ceiling height at
source image
distance 110 cm | 2.83 m to 3.21 m | 2.65 m to 3.20 m | Similar: Minor differences
in the Ceiling height does
not affect the safety or
effectiveness of the device. |
| Movement | 3.28 m to 3.44 m | 3.28 m to 3.44 m | Equivalent; No impact to
safety or effectiveness of
the device. |
| Transverse travel | 1.50 m to 3.22 m | 1.49 m to 3.21 m | Similar: Minor differences
in the Transverse travel do
not affect the safety or
effectiveness of the device. |
| Vertical travel | 1.65 m | 1.65 m | Equivalent; No impact to
safety or effectiveness of
the device. |
| X-ray tube
assembly rotation | • around vertical axis:
360° (±180°) with
lock position every
45°
• around horizontal
axis: ±125°, lock
positions 0° and ±90° | • around vertical axis:
360° (±180°) with
lock position every
45°
• around horizontal
axis: ±125°, lock
positions 0° and
±90° | Equivalent; No impact to
safety or effectiveness of
the device. |
| | Predicate Device:
Philips Eleva Workspot
for DigitalDiagnost
Release 4 with SkyPlate
Detectors / (K141736) | Proposed Device:
DigitalDiagnost C90
(K18xxxx) | Discussion & Conclusion |
| Length of rails | 4.3 m | 4.3 m | Equivalent; No impact to
safety or effectiveness of
the device. |
| Collimator | • Ralco P 225 ACS
DHHS
• Motorized automatic
collimation
• Manual overrule
possible
• With light field
indicator | • Ralco P 225 ACS
DHHS
• Motorized auto-
matic collimation
• Manual overrule
possible
• With light field
indicator
• With 2 Lasers and
Camera | Ralco Collimator R225
ACS is cleared by Ralco
K091517 (on 14, July
2009), Ralco P 225 ACS
DHHS is cleared by Letter
to File on 02, February
2016 based on K091517.
Laser and Camera are
already certified and cleared
as options in K091517.
Equivalent; No impact to
safety or effectiveness of
the device. |
| | Vertical Stand
Vertical moveable stand (VM) | | |
| Hardware | Counterbalanced rugged
column for motorized
vertical movement of the
detector unit | Counterbalanced
rugged column for
motorized vertical
movement of the
detector unit | Equivalent; No impact to
safety or effectiveness of
the device. |
| Vertical travel | 35 cm to 185 cm | 35 cm to 185 cm | Equivalent; No impact to
safety or effectiveness of
the device. |
| Horizontal travel | • Motorized: 3.475 m
• non-motorized: 3.71 m
• with extension rails,
motorized: 5.5 m
• with extension rails,
non-motorized: 5.5 m | • Motorized: 3.475 m
• with extension rails,
motorized: 5.5 m | Equivalent; No impact to
safety or effectiveness of
the device. |
| Swiveling range | 0° to 90° (right or left
orientated execution) | 0° to 90° (right or left
orientated execution) | Equivalent; No impact to
safety or effectiveness of
the device. |
| Lock-in positions | manual or every 15° | manual or every 15° | Equivalent; No impact to
safety or effectiveness of
the device. |
| | Fixed Vertical Stand (VS) | | |
| Hardware | Counterbalanced rugged
column for motorized
and manual vertical
movement of the detector | Counterbalanced
rugged column for
motorized and manual
vertical movement of
the detector | Equivalent; No impact to
safety or effectiveness of
the device. |
| Vertical travel | 30 cm to 180 cm | 30 cm to 180 cm | Equivalent; No impact to
safety or effectiveness of
the device. |
| | Predicate Device:
Philips Eleva Workspot
for DigitalDiagnost
Release 4 with SkyPlate
Detectors / (K141736) | Proposed Device:
DigitalDiagnost C90
(K18xxxx) | Discussion & Conclusion |
| Installation | Floor and wall attachment or floor only | Floor and wall attachment or floor only | Equivalent; No impact to safety or effectiveness of the device. |
| Fixed RAD
Detector | Pixium 4343RC | Pixium 4343RCE | The proposed
DigitalDiagnost C90
includes the fixed RAD
detector Pixium 4343RCE
used in the currently
marketed and reference
device, Pixium 4343 RCE
(K170113). Therefore,
there is no impact on the
safety or effectiveness of
the device. |
| Wireless Static
Detector | SkyPlate Detector family | SkyPlate Detector
family | Equivalent; No impact to safety or effectiveness of the device. |
| Generator | High-voltage generator 65kW or 80kW | High-voltage generator 65kW or 80kW | Equivalent; No impact to safety or effectiveness of the device. |
| Tube | High power X-ray Tube, Philips SRO 33100 | High power X-ray
Tube, Philips SRO
33100 | Equivalent; No impact to safety or effectiveness of the device. |
| SkyFlow | No | Yes | The proposed
DigitalDiagnost C90
includes the SkyFlow used
in the currently marketed
and reference device Eleva
Workspot with SkyFlow,
(K153318). Therefore,
there is no impact on the
safety or effectiveness of
the device. |
| Eleva Workspot | Yes | Yes | Equivalent; No impact to safety or effectiveness of the device. |
| SkyPlate Detector
Sharing | Yes | Yes | Equivalent; No impact to safety or effectiveness of the device. |
| Automatic Image
stitching | Yes | Yes | Equivalent; No impact to safety or effectiveness of the device. |
| Indications for Use | As part of a radiographic
system, the Philips Eleva
Workspot with SkyPlate
Detectors is intended to
acquire, process, store,
display and export | The DigitalDiagnost
C90 is intended to
acquire, process.
store, display and
export digital radio-
graphic images. The | Equivalent; The Indications
for Use for the proposed
DigitalDiagnost C90 is
more general in nature and
exactly the same as the
currently marketed and |
| Predicate Device:
Philips Eleva Workspot
for DigitalDiagnost
Release 4 with SkyPlate
Detectors / (K141736) | Proposed Device:
DigitalDiagnost C90
(K18xxxx) | Discussion & Conclusion | |
| digital radiographic
images. The Philips
Eleva Workspot with
SkyPlate Detectors is
suitable for all routine
radiography exams,
including specialist areas
like intensive care,
trauma, or pediatric
work, excluding
fluoroscopy, angio-
graphy &
mammography. | DigitalDiagnost C90 is
suitable for all routine
radiography exam-
inations, including
specialist areas like
intensive care, trauma
or pediatric work,
excluding fluoroscopy,
angiography and
mammography. | reference device, Philips
Eleva Workspot for
DigitalDiagnost
(K141736). | |
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DigitalDiagnost C90 Premarket Notification – Traditional 510(k)
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DigitalDiagnost C90 Premarket Notification – Traditional 510(k)
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Based on the information provided above, the DigitalDiagnost C90 is considered substantially equivalent to the currently marketed and predicate device, Philips Eleva Workspot for DigitalDiagnost (K141736, July 25, 2014) in terms of fundamental scientific technology.
Summary of Non-Clinical Data:
This 510(k) premarket notification contains technical documentation which includes nonclinical verification and validation tests as well as image quality testing. Tests were performed on the proposed DigitalDiagnost C90 according to the following international and FDArecognized consensus standards:
- ISO 14971, Medical devices. Application of risk management to medical devices ●
- . IEC 60601-1, Medical electrical equipment. General requirements for safety. Collateral standard. Safety requirements for medical electrical systems
- IEC 60601-1-2. Medical electrical equipment. General requirements for basic safety and ● essential performance. Collateral Electromagnetic compatibility. Requirements and tests
- . IEC 60601-1-3. Medical electrical equipment. General requirements for basic safety and essential performance. Collateral Standard: Radiation protection in diagnostic X-ray equipment
- . IEC 60601-2-54, Medical electrical equipment. Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
- . IEC 6220-1, Medical electrical equipment. Characteristics of digital X-ray imaging devices. Determination of the detective quantum efficiency
- IEC 62304, Medical device software. Software life-cycle processes
- IEC 60601-1-6. General requirements for basic safety and essential performance -. Collateral standard: Usability
- Guidance for the Submission of 510(k)s for Solid State X-Ray Imaging Devices, issued ●
DigitalDiagnost C90 Premarket Notification - Traditional 510(k) Page 12 of 13
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September 1, 2016
- . Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued May 11, 2005
- Pediatric Information for X-ray Imaging Device Premarket Notifications, Draft, issued May 10, 2012
- Guidance for the Submission of Premarket Notifications for Medical Image ● Management Device, issued July 27, 2000
The test results demonstrate that the proposed DigitalDiagnost C90 meets the acceptance criteria and is adequate for its intended use.
Based upon the same intended use, similar technology, software functionalities, same product configuration and administration, and similarity of materials, it can be concluded the proposed DigitalDiagnost C90 is substantially equivalent to the predicate device, Philips EasyDiagnost Eleva, in terms of intended use, design characteristics, and safety and effectiveness.
The subject device DigitalDiagnost C90 is a combination of cleared Philips devices (Eleva Workspot, Bucky Vision, Pixium 4343RCE). Testing for integration of devices into a fullyfunctional system has been successfully performed.
Summary of Clinical Data:
The proposed DigitalDiagnost C90 did not require a clinical study since substantial equivalence to the currently marketed and predicate device was demonstrated with the following attributes:
- . Design features;
- Indication for use;
- Fundamental scientific technology:
- Non-clinical performance testing including validation; and
- . Safety and effectiveness.
Substantial Equivalence Conclusion:
The comparison of technological characteristics, non-clinical performance data, safety testing, software validation, and clinical image concurrence data demonstrates that the device is as safe and effective as the predicate device. Philips Medical Systems concludes that the proposed DigitalDiagnost C90 is substantially equivalent to the legally marketed predicate device, Philips Eleva Workspot for DigitalDiagnost.